Active Ingredients

Octinoxate 4%

Purpose: Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating or immediately after towel drying
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
wear long-sleeve shirts, pants, hats and sunglasses
children under 6 months: Ask a doctor.

Other information

protect this product from excessive heat and direct sun
report serious adverse event to Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222

Inactive ingredients

WATER (AQUA), CYCLOPENTASILOXANE, ALCOHOL DENAT., ISONONYL ISONONANOATE, PEG-10 DIMETHICONE, BUTYLENE GLYCOL, KAOLIN, DIMETHICONE, DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, MAGNESIUM SULFATE, TRIMETHYLSILOXYSILICATE, ALUMINUM STARCH OCTENYLSUCCINATE, DIPENTAERYTHRITYL TETRABEHENATE/POLYHYDROXYSTEARATE, SODIUM CHLORIDE, FRAGRANCE (PARFUM), DIMETHICONE/PEG-10/15 CROSSPOLYMER, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, XANTHAN GUM, TRIFLUOROMETHYL C1-4 ALKYL DIMETHICONE, PROPYLENE CARBONATE, DISODIUM EDTA, CHLORPHENESIN, MYRICA PUBESCENS FRUIT WAX, RETINYL PALMITATE, ENANTIA CHLORANTHA BARK EXTRACT, OLEANOLIC ACID, MICA, IRON OXIDES (CI 77491/CI 77492/CI 77499), TITANIUM DIOXIDE (CI 77891).

Product Packaging - Tono 1

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 2

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 3

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 4

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 5

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

Product Packaging - Tono 7

YANBAL

BASE LÍQUIDA MATIFICANTE

MATTIFYING LIQUID FOUNDATION

SUNSCREEN

BROAD SPECTRUM

SPF 15

27 ml 0.9 fl oz

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 1
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERROUS OXIDE (UNII: G7036X8B5H)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:23319-0007-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	09/30/2024

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 3
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0009
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:23319-0009-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	09/30/2024

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 4
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0010-1	1 in 1 CARTON	11/15/2018	04/01/2021
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	04/01/2021

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 2
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:23319-0008-1	1 in 1 CARTON	11/15/2018
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	10/31/2024

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 5
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0011
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0011-1	1 in 1 CARTON	11/15/2018	01/01/2021
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	01/01/2021

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 TONO 7
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:23319-0012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MICA (UNII: V8A1AW0880)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALCOHOL (UNII: 3K9958V90M)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MORELLA PUBESCENS FRUIT WAX (UNII: 2N43GS24LV)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
WATER (UNII: 059QF0KO0R)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROUS OXIDE (UNII: G7036X8B5H)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:23319-0012-1	1 in 1 CARTON	11/15/2018	01/01/2021
1		27 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/15/2018	01/01/2021

Labeler - Yanbal USA, Inc. (001801369)

Name	Address	ID/FEI	Business Operations
Establishment
Yanbal de Colombia S.A.S.		880215657	manufacture(23319-0007, 23319-0008, 23319-0009, 23319-0010, 23319-0011, 23319-0012)

YANBAL BASE LIQUIDA MATIFICANTE MATTIFYING FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15

Active Ingredients

Uses

Warnings

Directions

Other information

Inactive ingredients

Company Information

Product Packaging - Tono 1

Product Packaging - Tono 2

Product Packaging - Tono 3

Product Packaging - Tono 4

Product Packaging - Tono 5

Product Packaging - Tono 7